JPH083053A - Therapeutic agent for steroid dermatosis and its production - Google Patents

Abstract

PURPOSE:To obtain a obtain steroid therapeutic agent for dermatosis having high safety, comprising an extract of tea, especially oolong tea as an active ingredient. CONSTITUTION:Leaves of oolong tea are naturally dried to remove 30-50% of water and stirred for several hours. Then the tea leaves are roasted by a pot and redried while rubbing. The prepared oolong tea leaves are extracted with 10-20 times as much as deionized water at 50-100 deg.C for 5-30 minutes, the extracted solution is adjusted to about pH5.0 with ascorbic acid and concentrated under reduced pressure at 40-60 deg.C to give a concentrated solution having 10-20 Brix or further dried to give dried powder. The dried powder is dissolved in warm water for bath as it is for drinking with warm water or is properly mixed with an additive for medicine and pharmaceutically manufactured. The prepared steroid therapeutic agent for dermatosis shows thermo-keeping effect, moisture retaining effect, antipruritic effect, normalizing effect on acanthosis and a lichen state and anti-inflammatory effect and is also useful as a therapeutic agent for atopic dermatitis.

Description

Detailed Description of the Invention

[0001]

TECHNICAL FIELD The present invention relates to a therapeutic agent for skin diseases, particularly a therapeutic agent effective for steroid dermatosis, and a method for producing the same.

[0002]

2. Description of the Related Art Various anti-inflammatory skin agents have been developed so far, but since the topical steroid preparations (corticosteroids) have been developed, they have been dramatically and rapidly effective. The pharmacological effect has brought about a revolutionary change in the treatment in the dermatological field, and this steroid external preparation is still used for various skin diseases. However, while this external preparation for steroids has excellent pharmacological effects as described above, it causes side effects such as steroid dermatosis when used for a long period of time, and further falls into a vicious circle in which external preparations for steroids must be used. I also had the problem of becoming drug dependent. In particular, when it is directly applied to the skin, there is a risk that the steroid drug may be absorbed from the lesion and systemic side effects may occur.

In addition to dermatological diseases, originally steroids are allergic to blood diseases, collagen diseases, asthma, shock, nephrosis, neurological diseases such as cerebral edema and neurodegenerative diseases, and respiratory diseases such as pulmonary fibrosis. It is also extremely useful as a therapeutic agent. However, since it is usually administered in a large amount, it is impossible to discontinue the administration once it is started to be used, and there is a risk of causing various side effects as well as steroid dermatosis in many cases.

Incidentally, in order to treat such steroid dermatosis, it is desirable to gradually reduce the amount of steroid used and to treat with a useful therapeutic agent. Is often weakened to the skin or the whole body due to skin diseases or taking drugs, and is of course superior in its pharmacological effect, but it is safer for the human body and can be used safely for a long period of time. A therapeutic agent that can do is desired. However, conventionally,
Such a therapeutic agent for steroid dermatosis has not been disclosed.

On the other hand, as for teas, for example, as disclosed by the present inventors in Japanese Patent Laid-Open No. 3-258726,
It has been confirmed that water-soluble tannins of tea have a histamine release inhibitory action and are particularly useful as anti-type I allergic agents. However, the idea that the tea extract can be applied to the treatment of steroid dermatosis, which is the object of the present invention, has not been suggested at all in the past.

[0006]

SUMMARY OF THE INVENTION Accordingly, the present inventors
In order to develop a therapeutic agent for the above steroid dermatosis, focusing on the safety and its pharmacological effect of teas that have been ingested daily since ancient times, a therapeutic agent for steroid dermatosis from various teas or tea leaves and a method for producing the same are provided. It is a good thing.

[0007]

The therapeutic agent for steroid dermatosis of the present invention for solving the above problems is a tea extract, preferably water to hot water extract, particularly preferably 50 to 10
A tea extract obtained by extraction with warm water at 0 ° C is used as an active ingredient, and has heat-retaining and moisturizing effects, antipruritic effect, normalization of epidermal thickening, and moss on skin with steroid dermatosis disease state. It is extremely useful as a therapeutic agent for steroid dermatosis because it exhibits normalization of the symptomatic state and anti-inflammatory effect and is highly safe.

The above-mentioned tea is fermented tea, semi-fermented tea or unfermented tea, preferably oolong tea. Particularly, after exposing the green tea leaves to sunlight, 30 to 50% of the water content of the tea leaves is removed at room temperature, and this tea is removed. It is preferable that the tea leaves are dried while stirring for several hours, roasting in a pot and kneading. As oolong tea, various semi-fermented teas and processed products thereof can be used.

The main active ingredient of the tea extract is mainly composed of tea tannins, for example, oolong tea tannin (oolong tannin). The composition of the tea tannins includes polyphenols (Flavan-3-ols) such as catechin, epicatechin, epicatechin gallate, and epigallocatechin gallate.

As the method for producing the above-mentioned therapeutic agent for steroid dermatosis, tea leaves obtained by drying fermented tea leaves, semi-fermented tea leaves or unfermented tea leaves, for example, 30 to 30% of the tea leaves after naturally dried.
After removing 50% of the water content of the tea leaves, the resulting dried tea leaves are extracted with water or hot water, preferably deionized water at 50 to 100 ° C., the extract is filtered to remove insolubles, and then this filtrate is preferably used. In order to stabilize the tea tannins, for example, an appropriate amount of vitamin C is added to adjust the extract to a low acid region,
This is concentrated under reduced pressure at 40 to 60 ° C to obtain a concentrated liquid, or the filtrate is dried to obtain a dry powder.

A further preferred example of the method for producing steroid dermatosis is as follows: Oolong tea leaves are naturally dried to about 30-50%.
After removing the water content and stirring for several hours, put the tea leaves in a kettle and dry again while rubbing the oolong tea leaves with about 10 to 20 times the amount of deionized water at about 50 to 100 ° C. After extracting for 5 to 30 minutes and removing the insoluble matter by filtering this extract, an appropriate amount of ascorbic acid is added to pH 5.0.
To about 40 ° C to 60 ° C under reduced pressure and concentrated to B
The concentration of rix is about 10 to 20 or is further dried to obtain a dry powder.

Further, the steroid dermatosis therapeutic agent of the present invention can be used as a dry powder as described above by dissolving it in hot water as it is, or by dissolving or dispersing it in a suitable liquid simple substance. Or mixed with a suitable powder or adsorbed on it,
If necessary, these may be further added with excipients, binders, disintegrants,
Addition of lubricants, stabilizers, flavoring agents, etc., for parenteral administration such as suppositories, ointments, injections or suppositories, or tablets, capsules, granules, powders or syrups. It can also be used for oral administration such as.

The amount of the therapeutic agent for steroid dermatosis of the present invention varies depending on the method of use, symptom or age. For example, when the therapeutic agent for steroid dermatosis in a dry powder is dissolved in hot water to be used in a hot water bath of an affected area, Brix for normal adults
It may be diluted to about 0.02 or more, preferably about 0.02 to 0.5.

[0014]

【Example】

(Manufacturing method of steroid dermatosis therapeutic agent) Oolong tea leaves about 4
After air-drying to remove 0% of water, stir for several hours, put in a pot and dry again while rubbing to obtain dried oolong tea leaves with 15 times amount of 90 ° C. deionized water.
Extracted for a minute, squeezed to obtain a juice, which was filtered to remove insoluble matter, and vitamin C was added to the obtained filtrate to adjust the pH to 5.3 to 5.6, Vacuum degree 720
Concentrate to Brix 15 at mmHg, temperature 40 ° C,
The concentrated liquid was dried to obtain a dry powder. The yield of the dry powder was about 19.6% by weight based on the dried oolong tea leaves.

The resulting dry powder had a dark brown light blue color when dissolved in water, and its taste had a weak astringency and sweetness.
The astringent stimulation of the taste nerve of the tongue was much weaker than that of green tea catechin.

(Clinical Study 1) The subject was a 21-year-old woman, who was diagnosed with atopic dermatitis in the latter half of her life.
Although it developed on the face, neck, hands, arms, and knees and steroid ointment was applied to these parts, the inflammation-suppressing effect was transient, and steroid dermatosis was present due to long-term use of topical steroids. Therefore, when a dry powder obtained by the above-mentioned manufacturing method was bathed in hot water diluted with Brix 0.05 once a day for 5 weeks, along with steroid withdrawal therapy, skin thickening and bulkiness were observed. The sensation, tightness and rash disappeared, the skin became moist, and the itchiness that was likely to be fine-grained disappeared. After that, it was also effective in the management of stubborn and persistent steroid dermatosis.

(Clinical study 2) The subject was a 20-year-old woman, who had been diagnosed with atopic dermatitis at about 2 years old, but had almost no symptoms, and from about 16 years atopy on her hands, face, etc. The dermatitis developed and the application of steroid ointment was started. However, the inflammation-suppressing effect was transient, and the symptom of the affected area became more tingly and became more feverish, resulting in steroid dermatosis. After that, the use of steroid ointment was stopped, but the symptom was in a more advanced state. Therefore, the dry powder obtained by the above-described manufacturing method was applied to a subject together with steroid withdrawal therapy by Brix0.0.
After bathing in hot water diluted to 5 once a day for 5 weeks,
The thickening, bulkiness, tightness, rash, etc. of the skin were improved, and after 8 weeks, the skin became moist, and the itching sensation became fine, and lesions on the skin could not be observed. After that, it was effective for the management of stubborn and persistent steroid dermatosis.

(Clinical Trial 3) A 29-year-old man was diagnosed with atopic dermatitis at the first year of junior high school, and he began to visit the hospital and was treated by applying a steroid hormone drug to the affected area or the whole body. At the age of 20, the rash decreased. Since then, he has been using this steroid drug, but since he had developed steroid dermatosis and had become addicted to steroid drugs, he discontinued the use of this drug in 1989 and switched to zinc flower ointment. However, it only suppressed the itching sensation. Therefore, the dry powder obtained by the above manufacturing method was diluted with hot water diluted with Brix 0.02 once a day for 5 times.
After taking a hot bath for a week, the rash decreased, the itching sensation improved, and the skin texture became fine. Also after that, skin thickening, bulkiness, tightness, such as steroid skin symptoms,
No recurrence such as a rash was confirmed.

The steroid dermatosis therapeutic agent of the present invention is also dissolved in hot water to prepare a solution of Brix 0.02 to 0.5, which is filled in a bath and the bath is continued for several days to several weeks. The stubborn pruritus and rash of dermatosis were alleviated, and more comfortable daily management became possible, and the clinical effect was also confirmed against pruritus and rash caused by early atopic dermatitis.

[0020]

INDUSTRIAL APPLICABILITY According to the present invention, tea, which has the advantage of being easily available and consumed on a daily basis for many years and having a particularly high safety as compared with synthetic products, particularly oolong tea, is used as a basic disease with atopic dermatitis. It is possible to provide a therapeutic agent for steroid dermatosis having an unprecedented effect on alleviating the symptoms of itch and rash of steroid dermatosis, which is extremely difficult to treat today. Further, it can be provided as a therapeutic agent for atopic dermatitis of underlying diseases.

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[Procedure amendment]

[Submission date] June 28, 1994

[Procedure Amendment 1]

[Document name to be amended] Statement

[Correction target item name] 0011

[Correction method] Change

[Correction content]

A more preferred example of the method for producing a therapeutic agent for steroid dermatosis is to dry oolong tea leaves by about 30 to 30% by natural drying.
After removing 50% of water and then stirring for several hours, the tea leaves are put in a pot and dried again while rubbing to obtain oolong tea leaves, which is about 10 to 20 times the amount of deionized water at about 50 to 100 ° C. After about 5 to 30 minutes, the extract is filtered to remove the insoluble matter, and an appropriate amount of ascorbic acid is added to add PH.
It is adjusted to about 5.0 and concentrated under reduced pressure at about 40 to 60 ° C. to obtain a concentrated solution of Brix of about 10 to 20, or further dried to obtain a dry powder.

[Procedure Amendment 2]

[Document name to be amended] Statement

[Correction target item name] 0012

[Correction method] Change

[Correction content]

Further, the steroid dermatosis therapeutic agent of the present invention can be used as a dry powder as described above by dissolving it in hot water as it is, or by dissolving or dispersing it in a suitable liquid simple substance. Or mixed with a suitable powder or adsorbed on it,
If necessary, these may be further added with excipients, binders, disintegrants,
Lubricants, stabilizers, flavoring agents, etc. may be added for parenteral administration such as suppositories, ointments or suppositories, or orally by tablets, capsules, granules, powders or syrups. It can also be used for administration.

 ─────────────────────────────────────────────────── ─── Continuation of the front page (72) Inventor Yasuhiko Fukui 3-5-5, Kudan Minami, Chiyoda-ku, Tokyo Medical Law Entrepreneur Eifukukai Clinic Fukui (72) Inventor, Kazuhiko Fukui 3-Kandan Minami, Chiyoda-ku, Tokyo 5-5 Medical Law Inside Efukukai Clinic Fukui

Claims (11)

[Claims] 1. A therapeutic agent for steroid dermatosis, which comprises a tea extract as an active ingredient. 2. The therapeutic agent for steroid dermatosis according to claim 1, wherein the tea is fermented tea, semi-fermented tea or unfermented tea. 3. The therapeutic agent for steroid dermatosis according to claim 1, wherein the tea is oolong tea. 4. The therapeutic agent for steroid dermatosis according to claim 1, wherein the tea extract is a water or hot water extract. 5. The tea extract is an extract obtained by extraction with warm water at 50 to 100 ° C.
The therapeutic agent for steroid dermatosis according to any one of 4 above. 6. A therapeutic agent for steroid dermatosis containing tannins as a main component. 7. The oolong tea tannin (oolong tannin)
A remedy for steroid dermatosis containing as a main component. 8. Fermented tea leaves, semi-fermented tea leaves or unfermented tea leaves are removed to remove about 30 to 50% of the water content of the tea leaves, and after stirring for several hours, the tea leaves are put in a pot and dried while rubbing, A method for producing a therapeutic agent for steroid dermatosis, which comprises extracting this with water or hot water. 9. The method for producing a therapeutic agent for steroid dermatosis according to claim 8, wherein the tea leaves are extracted with warm water at 50 to 100 ° C. 10. Tea leaves obtained by drying fermented tea leaves, semi-fermented tea leaves or unfermented tea leaves are extracted with water or hot water, the obtained extract is filtered to remove insoluble matter, and A method for producing a therapeutic agent for steroid dermatosis, which comprises adjusting the filtrate to a low acidic region and concentrating it under reduced pressure to obtain a concentrated solution or drying the filtrate to obtain a dry powder. 11. Oolong tea leaves are naturally dried to about 30-5.
After removing 0% of water and stirring for several hours, put tea leaves in a pot and dry again while rubbing them to obtain oolong tea leaves, which is about 10 to 20 times the amount of deionized water at about 50 to 100 ° C. After about 5 to 30 minutes, the extract is filtered to remove the insoluble matter, and an appropriate amount of ascorbic acid is added to add PH.
A method for producing a therapeutic agent for steroid dermatosis, which is prepared to about 5.0 and concentrated under reduced pressure at about 40 to 60 ° C. to give a concentrated solution of Brix of about 10 to 20, or further dried to obtain a dry powder.